Trial Outcomes & Findings for Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (NCT NCT01788150)
NCT ID: NCT01788150
Last Updated: 2021-05-04
Results Overview
Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
6-months post-procedure
Results posted on
2021-05-04
Participant Flow
Participant milestones
| Measure |
Svelte Drug-Eluting Coronary Stent
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
51
|
|
Overall Study
COMPLETED
|
95
|
48
|
|
Overall Study
NOT COMPLETED
|
13
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
Baseline characteristics by cohort
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
33 participants
n=5 Participants
|
20 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
24 participants
n=5 Participants
|
16 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
26 participants
n=5 Participants
|
6 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
14 participants
n=5 Participants
|
2 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-months post-procedureDefined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=89 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=40 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Angiographic In-Stent Late Lumen Loss (LL)
|
0.09 mm
Standard Deviation 0.31
|
0.13 mm
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 1 year post-procedureClinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Clinically-driven Target Lesion Revascularization (TLR)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year post-procedureComposite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year post-procedureComposite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 year post-procedureThe sudden occlusion of a stented coronary artery due to thrombus formation.
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Stent Thrombosis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From index procedure to hospital discharge, an average of 24 hoursDirect Stenting Success, Lesion Success, Procedure Success and Device Failure
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Acute Success Rates
Device Failure
|
2 Participants
|
0 Participants
|
|
Number of Participants Acute Success Rates
Direct Stenting Success
|
96 Participants
|
45 Participants
|
|
Number of Participants Acute Success Rates
Lesion Success
|
104 Participants
|
51 Participants
|
|
Number of Participants Acute Success Rates
Procedure Success
|
103 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 6-months post-procedurePopulation: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
The rate which restenosis occurs
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=89 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=40 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
In-stent angiographic binary restenosis rate
|
2 Participants
|
0 Participants
|
|
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
In-segment angiographic binary restenosis rate
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-months post-procedurePopulation: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
Smallest diameter in the stent or segment area
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=89 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=40 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
In-stent and In-segment Minimum Lumen Diameter
In-stent minimum lumen diameter
|
2.28 mm
Standard Deviation 0.46
|
2.52 mm
Standard Deviation 0.45
|
|
In-stent and In-segment Minimum Lumen Diameter
In-segment minimum lumen diameter
|
2.07 mm
Standard Deviation 0.48
|
2.26 mm
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 6-months post-procedurePopulation: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=89 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=40 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
In-segment Late Lumen Loss
|
0.04 mm
Standard Deviation 0.33
|
-0.02 mm
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 6-months post proceduresPopulation: 8 Subjects in the Svelte Arm refused to have the follow-up OCT at 6 months. This was only measureed in the Svelte arm.
(% lumen volume)
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=22 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Neointimal Hyperplasia as Measured by OCT
|
11.3 percentage of lumen volume
Standard Deviation 4.7
|
—
|
SECONDARY outcome
Timeframe: 6-months post procedurePopulation: 8 Subjects in the Svelte Arm refused to have the follow-up OCT at 6 months. This was only measured int he Svelte arm
(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=22 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Strut Coverage
|
94.2 % strut coverage
Standard Deviation 9.0
|
—
|
SECONDARY outcome
Timeframe: 1 year post procedureComposite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Outcome measures
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 Participants
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 Participants
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Number of Participants Target Vessel Failure
|
7 Participants
|
5 Participants
|
Adverse Events
Svelte Drug-Eluting Coronary Stent
Serious events: 21 serious events
Other events: 36 other events
Deaths: 0 deaths
Medtronic Resolute Integrity Drug-Eluting Stent
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 participants at risk
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 participants at risk
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Cardiac disorders
Angina
|
1.9%
2/108 • Number of events 2
|
0.00%
0/51
|
|
Cardiac disorders
Arrhythmia
|
0.93%
1/108 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
Cardiac decompensation
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Endocrine disorders
HYperthyroidism
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Gastrointestinal disorders
GI Bleed
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Infections and infestations
Local Infection
|
0.00%
0/108
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Depression
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Nervous system disorders
Fainting/Syncope/Vasovagal Reaction
|
0.00%
0/108
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/108
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Renal and urinary disorders
Renal Failure/Insufficiency
|
0.00%
0/108
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Atypical Chest Pain
|
0.93%
1/108 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
|
Immune system disorders
Fever/Pyrexia
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
General disorders
Chest pain wihtout cardiac enzyme elevation
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrium Carcinoma
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
General disorders
Black-out after drinking wine
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Vascular disorders
Carotid Stenosis
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Cardiac disorders
Silent Ischemia
|
0.93%
1/108 • Number of events 1
|
0.00%
0/51
|
|
Vascular disorders
Claudication
|
1.9%
2/108 • Number of events 2
|
0.00%
0/51
|
|
Vascular disorders
Restenosis
|
0.00%
0/108
|
2.0%
1/51 • Number of events 1
|
Other adverse events
| Measure |
Svelte Drug-Eluting Coronary Stent
n=108 participants at risk
Coronary Stenting
Coronary Stenting
|
Medtronic Resolute Integrity Drug-Eluting Stent
n=51 participants at risk
Coronary Stenting
Coronary Stenting
|
|---|---|---|
|
Cardiac disorders
MI
|
12.0%
13/108 • Number of events 13
|
21.6%
11/51 • Number of events 11
|
|
Cardiac disorders
Elevated cardiac enzymes
|
7.4%
8/108 • Number of events 8
|
5.9%
3/51 • Number of events 3
|
|
Vascular disorders
Dissection
|
8.3%
9/108 • Number of events 9
|
0.00%
0/51
|
|
General disorders
Atypical Chest pain
|
5.6%
6/108 • Number of events 6
|
0.00%
0/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place